- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07825805
Hand Position, CPR Quality and Rescuer Comfort
Effect of Hand Position During Chest Compressions on Resuscitation Quality and Rescuer Comfort: A Randomized Crossover Simulation Study
Přehled studie
Postavení
Podmínky
Detailní popis
High-quality chest compressions are a key component of cardiopulmonary resuscitation (CPR). Current international resuscitation guidelines recommend placing one hand on top of the other during chest compressions, but recommendations regarding whether the fingers should be interlocked or simply placed on top of each other are based on limited scientific evidence.
This prospective, randomized, controlled crossover simulation study will compare two hand positions during continuous chest compressions on an adult CPR manikin. Each participant will perform two 2-minute chest compression periods, using both techniques in a computer-randomized order: (1) interlocked fingers, representing the commonly taught technique, and (2) non-interlocked hands placed one on top of the other. A 10-minute seated rest period will separate the two measurement periods.
The primary outcome will be mean chest compression depth. Secondary outcomes will include compression rate, proportion of compressions with adequate depth and full chest recoil, temporal changes in compression depth, and subjective assessments of pain, discomfort, physical fatigue, hand-position stability, and confidence in performing chest compressions. Participants will also indicate which technique they would prefer in a real resuscitation situation.
The study will be conducted in a simulation environment at the Human Patient Simulation Center of the University of Pécs Faculty of Health Sciences. Participants will not receive real-time feedback from the manikin during the measurements.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Bálint Bánfai, PhD
- Telefonní číslo: +3672501-500
- E-mail: balint.banfai@etk.pte.hu
Studijní místa
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Pécs, Maďarsko, 7621
- Nábor
- University of Pecs
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Kontakt:
- Bálint Bánfai, PhD
- Telefonní číslo: +3672501-500
- E-mail: balint.banfai@etk.pte.hu
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Adults aged 18 years or older
- Healthcare professionals or laypersons
- Physically able to perform chest compressions
- Able and willing to provide written informed consent to participate in the study
Exclusion Criteria:
- Acute injury of the upper extremities
- Chronic musculoskeletal disease or symptoms that may interfere with the ability to perform chest compressions with adequate quality
- technical issue during data collection
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Interlocked fingers
Participants will perform continuous chest compressions using the interlocked-finger hand position.
One hand will be placed on the lower half of the sternum, with the other hand placed on top and the fingers interlocked.
Chest compressions will be performed for 2 minutes according to current international CPR recommendations, targeting a compression depth of 5-6 cm, a rate of 100-120 compressions per minute, and complete chest recoil after each compression.
No real-time feedback from the manikin will be provided during the measurement.
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Participants will perform chest compressions using the interlocked-finger hand position.
One hand will be placed on the lower half of the sternum and the other hand on top, with the fingers interlocked.
The intervention will consist of 2 minutes of continuous chest compressions performed at a target rate of 100-120 compressions per minute and a target depth of 5-6 cm, with complete chest recoil after each compression.
No real-time feedback will be provided.
|
|
Aktivní komparátor: Overlapped hands
Participants will perform continuous chest compressions using the non-interlocked hand position.
One hand will be placed on the lower half of the sternum, with the other hand placed directly on top without interlocking the fingers.
Finger contact between the two hands will be permitted, but active interlocking will not be performed.
Chest compressions will be performed for 2 minutes under the same conditions as the interlocked-finger condition, targeting a compression depth of 5-6 cm, a rate of 100-120 compressions per minute, and complete chest recoil after each compression.
No real-time feedback from the manikin will be provided during the measurement.
|
Participants will perform chest compressions using the non-interlocked hand position.
One hand will be placed on the lower half of the sternum and the other hand on top without interlocking the fingers.
The intervention will consist of 2 minutes of continuous chest compressions performed under the same conditions as the interlocked-finger technique, with a target rate of 100-120 compressions per minute, a target depth of 5-6 cm, and complete chest recoil after each compression.
No real-time feedback will be provided.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Mean chest compression depth (mm)
Časové okno: During procedure.
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Mean chest compression depth recorded continuously by the manikin's integrated measurement system during CPR performance.
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During procedure.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Chest compression rate (per minute)
Časové okno: During procedure.
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Mean chest compression rate (compressions per minute) recorded by the manikin's integrated measurement system during CPR performance.
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During procedure.
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Proportion of compressions with adequate depth (%)
Časové okno: During procedure.
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Proportion of chest compressions meeting the predefined target depth, as recorded by the manikin's integrated measurement system.
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During procedure.
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Proportion of compressions with complete chest recoil (%)
Časové okno: During procedure.
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Proportion of chest compressions followed by complete chest recoil, as recorded by the manikin's integrated measurement system.
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During procedure.
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Interruption duration (sec)
Časové okno: During procedure.
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Duration of interruptions in chest compressions (hand-off time), if applicable, recorded by the manikin's integrated measurement system.
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During procedure.
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Overall chest compression quality score (points, mean, SD)
Časové okno: During procedure.
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Overall chest compression quality score calculated by the manikin's integrated measurement system based on predefined CPR performance parameters.
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During procedure.
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Self-reported hand pain
Časové okno: Immediately after the CPR procedure (within 15 minutes)
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Participants' self-reported overall hand pain following CPR performance, assessed using a 0-10 Numeric Rating Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain.
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Immediately after the CPR procedure (within 15 minutes)
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Finger discomfort
Časové okno: Immediately after the CPR procedure (within 15 minutes)
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Participants' self-reported discomfort in the fingers following CPR performance, assessed using a 0-10 Numeric Rating Scale.
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Immediately after the CPR procedure (within 15 minutes)
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Wrist discomfort
Časové okno: Immediately after the CPR procedure (within 15 minutes)
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Participants' self-reported wrist discomfort following CPR performance, assessed using a 0-10 Numeric Rating Scale.
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Immediately after the CPR procedure (within 15 minutes)
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Perceived physical fatigue
Časové okno: Immediately after the CPR procedure (within 15 minutes)
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Participants' self-reported physical fatigue following CPR performance, assessed using a 0-10 Numeric Rating Scale.
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Immediately after the CPR procedure (within 15 minutes)
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Perceived hand-position stability
Časové okno: Immediately after the CPR procedure (within 15 minutes)
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Participants' perceived stability of their hand position during CPR performance, assessed using a 0-10 Numeric Rating Scale.
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Immediately after the CPR procedure (within 15 minutes)
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Perceived hand slippage
Časové okno: Immediately after the CPR procedure (within 15 minutes)
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Participants' perceived sensation of hand slippage during CPR performance, assessed using a 0-10 Numeric Rating Scale.
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Immediately after the CPR procedure (within 15 minutes)
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Preferred hand position
Časové okno: Immediately after the CPR procedure (within 15 minutes)
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Participants' preferred hand position for performing CPR in a real-life cardiac arrest situation.
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Immediately after the CPR procedure (within 15 minutes)
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Bálint Bánfai, PhD, University of Pécs Faculty of Health Sciences
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- CPR hand position
Plán pro data jednotlivých účastníků (IPD)
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